MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; ENDOSCOPE

Model Number	470026-64
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.Fse performed troubleshooting on the 0-degree endoscope, however no issues were observed.The customer stated they had the same issue approximately one week previously with a 30-degree scope that was returned for rma.Fse replaced the endoscope controller (ec).Isi received the 0-degree endoscope involved with this complaint and completed the device evaluation.Failure analysis investigations confirmed and replicated the customer reported complaint.Upon visual inspection, holes were noted in the teflon wrap, and the endoscope adapter was found damaged.No issue was noted with either image.The heat shrink was observed to be too short.
Event or Problem Description
It was reported during a da vinci-assisted ventral hernia surgical procedure, interference was experienced when firing the cautery instrument.The customer started to covert the case to laparoscopic surgery before calling intuitive surgical, inc.(isi) technical support.The customer declined to troubleshoot with an isi technical support engineer (tse).Prior to the call, the customer stated the monopolar instrument cord was replaced and they moved the erbe power cords from one outlet to another, however the issue persisted.Tse reviewed live system logs and observed video loss errors in the logs, pointing to the endoscope.Tse stated that the issue is likely specific to the endoscope and recommended discontinuing use.The procedure was completed laparoscopically with no reported injury to the patient.

• Brand Name: NONE
• Common Device Name: ENDOSCOPE
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 17015857
• Report Number: 2955842-2023-14980
• Device Sequence Number: 12653783
• Product Code: NAY
• UDI-Device Identifier: 00886874112205
• UDI-Public: (01)00886874112205
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K171426
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 470026-64
• Device Catalogue Number: 470026
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 05/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Age: 63 YR
• Patient Sex: Male